Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with stage IV non-small cell lung cancer (NSCLC), or NSCLC that has come back and cannot be treated with a combination of standard therapies.
• People whose cancer has a specific genetic change called an ALK rearrangement, confirmed by one of four accepted laboratory tests (FISH, IHC, tissue gene testing, or blood-based gene testing).
• People who are either new to ALK-targeted treatment, or who have been taking lorlatinib as a first treatment for up to 12 weeks without their cancer getting worse, or who have been taking alectinib, brigatinib, or ensartinib for 4 weeks or less without their cancer getting worse (those on these three medicines would need to switch to lorlatinib to participate).
• People whose treating doctor considers them a suitable candidate for a type of focused local treatment to specific areas of cancer.
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2).
• People aged 18 or older.
• People whose blood tests show that their kidneys, liver, blood cells, and clotting system are working at an acceptable level (specific lab value thresholds apply — confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test at the start of the screening process.
• Women who could become pregnant must agree to use a highly effective form of contraception from the time they sign their consent form until 4 months after their last dose of the study medicine, or agree to completely abstain from heterosexual intercourse during that period. Women who are postmenopausal (no periods for 12 or more months in a row), or who have had a hysterectomy or surgical sterilisation, meet the contraception requirement through those circumstances.
• Men, including those who have had a vasectomy, must agree to use effective barrier contraception throughout the treatment period and for 4 months after their last dose, or agree to completely abstain from heterosexual intercourse during that period.
• People with a normal heart rhythm measurement on an ECG at screening (specific QTc interval thresholds apply — confirm with trial site).
• People who are willing and able to give written informed consent and to follow all parts of the study plan.

Who may not be able to join:

• People who have had another type of cancer in addition to NSCLC, unless it was a minor skin cancer, cervical cancer in situ, prostate cancer that was fully treated and did not spread, or another cancer for which curative treatment was completed at least 2 years ago.
• People who have previously taken any ALK-targeted treatment or other targeted therapy of this type (except for the currently allowed first-line medicines described in the inclusion criteria).
• People who have already received more than one cycle of chemotherapy, with or without immunotherapy, for advanced or metastatic disease.
• People who have brain metastases causing symptoms, or asymptomatic brain metastases that have required an increasing dose of steroid medication within the 7 days before enrolment.
• People who currently have compression of the spinal cord, whether or not it is causing symptoms, as seen on imaging.
• People who have a lung condition involving inflammation or scarring of the lung tissue (interstitial lung disease, drug-related or radiation-related lung inflammation) at the time of screening.
• People with a known or suspected allergy to lorlatinib or any of its ingredients.
• People who have a condition affecting how the gut absorbs medicines taken by mouth.
• People with high blood pressure that is not being controlled with treatment.
• People who have had radiation therapy within 14 days before joining the trial, except for certain precise, targeted forms of radiation therapy (SRS or SBRT).
• People who have had major surgery within 30 days before enrolment (minor procedures such as a biopsy or catheter placement are generally acceptable).
• People with serious heart conditions, including a heart attack or unstable chest pain within the past 6 months, significant heart failure, or a history of clinically significant irregular heartbeat.
• People who have had a stroke within 6 months before starting the study medicine.
• People with an active or ongoing infection, including those currently needing antibiotics given through a drip.
• People who would need to continue taking other anti-cancer treatments (such as chemotherapy, immunotherapy, or biological therapies) while taking part in this study.
• People with a history of allergic reactions to medicines that are chemically similar to lorlatinib.
• People with a known history of HIV infection.
• People who are pregnant, as lorlatinib may harm an unborn baby.
• People who are breastfeeding, as the potential risk to a nursing infant is unknown.

Important: Always verify eligibility with the trial site directly before applying.